LGS: Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children

Sponsor

LG Chem (Industry)

Overall Status

Recruiting

CT.gov ID

NCT01604395

Collaborator

(none)

6,000

Enrollment

Location

252

Duration (Months)

23.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS (Idiopathic Short Stature).

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Deficiency Turner Syndrome Chronic Renal Failure Small for Gestational Age Idiopathic Short Stature

Study Design

Study Type:

Observational

Anticipated Enrollment :

6000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

An Open, Multi-center, Prospective and Retrospective Observational Study to Evaluate the Long-term Safety and Effectiveness of Growth Hormone (Eutropin Inj. / Eutropin Plus Inj.) Treatment With GHD, TS, CRF, SGA, ISS and PWS in Children

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Dec 31, 2032

Anticipated Study Completion Date :

Dec 31, 2032

Arms and Interventions

Arm	Intervention/Treatment
growth hormone

Outcome Measures

Primary Outcome Measures

Safety measure : adverse event [up to 2 years after epiphyseal closure]

Secondary Outcome Measures

effectiveness measure : difference in target height and final height [up to 2 years after epiphyseal closure]
effectiveness : difference in height velocity between Baseline and every year [up to 2 years after epiphyseal closure]
effectiveness measure : difference in height SDS for CA between baseline and every 6 months [up to 2 years after epiphyseal closure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

short stature children aged 2 years or more
children with GHD,TS, CRF, SGA or ISS
written informed consent from the person, person's parent or legal guardian

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

LG Chem

Investigators

Principal Investigator: HW Chae, M.D., Kangnam severance hospital
Principal Investigator: KS Sim, M.D., Kangdong KyungHee University hospital
Principal Investigator: IT Hwang, M.D., Kangdong Sacred Heart Hospital
Principal Investigator: SC Chung, M.D., Konkook University hospital
Principal Investigator: CW Ko, M.D., Kyungpook National University Hospital
Principal Investigator: HS Kim, M.D., Keimyung University hospital
Principal Investigator: YJ Lee, M.D., Korea University
Principal Investigator: KH Lee, M.D., Korea University Anam Hospital
Principal Investigator: JH Lee, M.D., Kosin university hospital
Principal Investigator: JS Yu, M.D., Dankook University
Principal Investigator: JH Yu, M.D., Dong-A University Hospital
Principal Investigator: SY Lee, M.D., SMG-SNU Boramae Medical Center
Principal Investigator: WY Chung, M.D., Inje University
Principal Investigator: Yl Shin, M.D., Buchun Soonchunhyang university hospital
Principal Investigator: CY Kim, M.D., daejin medical center
Principal Investigator: DK Jin, M.D., Samsung Medical Center
Principal Investigator: MJ Park, M.D., Inje University
Study Chair: CH Shin, M.D., Seoul National University Hospital
Principal Investigator: BK Suh, M.D., Seoul St. Mary's Hospital
Principal Investigator: HW Yoo, M.D., Asan Medical Center
Principal Investigator: MH Jung, M.D., Yeouide St. Mary's hospital
Principal Investigator: SH Park, M.D., St. Vincent's Hospital-Manhattan
Principal Investigator: DH Kim, M.D., Sowha children's hospital
Principal Investigator: DH Lee, M.D., Seoul Soonchunhyang university hospital
Principal Investigator: HS Kim, M.D., Sinchon severance hospital
Principal Investigator: JS Hwang, M.D., Ajou University School of Medicine
Principal Investigator: SY Kim, M.D., Pusan National University Yangsan Hospital
Principal Investigator: JD Kim, M.D., Wonkwang university school of medicine & hospital
Principal Investigator: HS Han, M.D., Chungbuk National University Hospital
Principal Investigator: KH Lee, M.D., Wonkwang University Sanbon Medical Center
Principal Investigator: EK Yoo, M.D., Bunsangcha hospital
Principal Investigator: BK Lim, M.D., Wonju Christian Hospital
Principal Investigator: JH Kang, M.D., Eulji University Hospital
Principal Investigator: JY Seo, M.D., Eulji General Hospital
Principal Investigator: HS Kim, M.D., ehwa university medical center
Principal Investigator: JE Lee, M.D., Inha University Hospital
Principal Investigator: JH Kim, M.D., Inje University
Principal Investigator: CJ Kim, M.D., Chonnam National University Hospital
Principal Investigator: DY Lee, M.D., Chonbuk National University Hospital
Principal Investigator: KS Shin, M.D., Jeju National University Hospital
Principal Investigator: IT Hwang, M.D., Hallym University Medical Center
Principal Investigator: SM Lee, M.D., Hanyang University
Principal Investigator: KH Lee, M.D., Korea University Guro Hospital
Principal Investigator: KS Jo, M.D., Bucheon St. Mary's Hospital
Principal Investigator: SY Ahn, M.D., KangWon National University Hospital
Principal Investigator: PS Oh, M.D., Chuncheon Sacred Heart Hospital
Principal Investigator: S Yang, M.D., Hallym University Kangnam Sacred Heart Hospital
Principal Investigator: EY Kim, M.D., Chosun University Hospital